Senna-Lax

SENNA-LAX- sennosides a and b tablet, film coated
Bryant Ranch Prepack

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredient (in each tablet)

Sennosides 8.6 mg

Purpose

Laxative

Uses

• relieves occasional constipation (irregularity)
• generally produces a bowel movement in 6-12 hours

Warnings

Do not use

• laxative products for longer than 1 week unless directed by a doctor

Ask a doctor before use if you have

• stomach pain
• nausea
• vomiting
• noticed a sudden change in bowel habits that continues over a period of 2 weeks

Stop use and ask a doctor if

you have rectal bleeding or fail to have a bowel movement after use of a laxative.

These may indicate a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• take preferably at bedtime or as directed by a doctor

age	starting dosage	maximum dosage
adults and children 12 years of age and older	2 tablets once a day	4 tablets twice a day
children 6 to under 12 years of age	1 tablet once a day	2 tablets twice a day
children 2 to under 6 years of age	1/2 tablet once a day	1 tablet twice a day
children under 2 years of age	ask a doctor	ask a doctor

Inactive ingredients

Acacia Gum, Calcium Carbonate, Croscarmellose Sodium, Dextrose, Hypromellose, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Propylene Glycol, Silicon Dioxide, Stearic Acid, Triacetin.

Questions?

Adverse Drug Event call (800) 616-2471

Sennosides 8.6mg Tablet

SENNA-LAX sennosides a and b tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63629-3207(NDC:0904-5165) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SENNOSIDES A AND B (SENNOSIDES A AND B) SENNOSIDES A AND B 8.6 mg

Inactive Ingredients Ingredient Name Strength ACACIA CALCIUM CARBONATE CROSCARMELLOSE SODIUM DEXTROSE HYPROMELLOSES MAGNESIUM STEARATE MALTODEXTRIN CELLULOSE, MICROCRYSTALLINE PROPYLENE GLYCOL SILICON DIOXIDE STEARIC ACID TRIACETIN

Product Characteristics Color brown Score 2 pieces Shape ROUND (Biconvex) Size 9mm Flavor Imprint Code GPI;W2 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:63629-3207-1 100 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:63629-3207-2 60 TABLET, FILM COATED in 1 BOTTLE None 3 NDC:63629-3207-3 120 TABLET, FILM COATED in 1 BOTTLE None 4 NDC:63629-3207-4 56 TABLET, FILM COATED in 1 BOTTLE None 5 NDC:63629-3207-5 30 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 05/04/2011

Labeler — Bryant Ranch Prepack (171714327)

Registrant — Bryant Ranch Prepack (171714327)

Establishment
Name	Address	ID/FEI	Operations
Bryant Ranch Prepack		171714327	REPACK (63629-3207), RELABEL (63629-3207)

Revised: 10/2012 Bryant Ranch Prepack